Kornimate/medical-research-clean huggingface dataset:
quality of life among breast reduction patients

Conditions: Breast Hypertrophy

Summary: despite the growing evidence showing that breast hypertrophy is associated with reduced health-related quality of life (hrql) and that reduction mammoplasty has a significant positive impact on hrql, there are unresolved issues that need to be addressed. these include our ability to measure quantitatively the change that occurs after reduction and the ongoing restriction or denials of third party payments based on body mass index (bmi). the primary purpose of this study is to assess and measure the hrql experienced by breast reduction patients using four reliable and validated hrql measures. fifty-two consecutive patients with the diagnosis of breast hypertrophy were invited to participate in this prospective study. participants completed the health utilities index mark 2 (hui2) and mark 3 (hui3) and the breast reduction assessment value and outcomes (bravo) instruments (the short form 36, the multidimensional body-self rating questionnaire appearance assessment, and the breast related symptom questionnaire) at one week and one day pre-surgery and one, six, and 12 months post-surgery.

this study addresses the following questions of clinical and policy relevance: 1) is the pre-surgery hrql of these patients compromised and, if so, in which areas? 2) do patients' hrql improve after surgery and, if so, when and in which areas and by how much? 3) is there a relationship between bmi and pre-/post-surgery changes in hrql (i.e., is the pre/post effect similar for both obese and non-obese patients)? and 4) is there a relationship between tissue re-section weight and pre-/post-surgery changes in hrql (i.e., is the pre/post hrql effect similar for patients having small and large amounts of tissue resected)?

Eligibility criteria:
inclusion criteria: * diagnosis of breast hypertrophy * government approval for payment of reduction mammoplasty exclusion criteria: * unable or unwilling to complete the quality of life questionnaires

Keywords: breast hypertrophy breast reduction surgery health-related quality of life health utilities index hui prospective sf-36 quality-adjusted life years qaly
changes in the microenvironment of hpv-induced head and neck cancers in west indies and metropolitan population

Conditions: Immunotherapy

Summary: retrospective observational comparative and multicentric study of the microenvironment of hpv-induced head and neck cancers, with comparison between west indies and metropolitan populations, and therapeutic implications. this assessment is carried out by in situ multiparametric study with multiple immunofluorescence staining for cluster of differentiation 3, cluster of differentiation 4, cluster of differentiation 8, programmed death-1, programmed death-l1, programmed death-l2, cytokeratin and cluster of differentiation 68 and automated reading. hpv genotypes will be characterized. learning these techniques will allow me to promote them in west indies on my way back, and they may be applicable to other hpv-induced cancers.

global annual incidence of head and neck (hn) cancers is high. it is even a greater concern in west indies compared to other american countries. most represented histological type is squamous carcinoma and several risk factors are involved , including tobacco exposure. moreover, it is now clear that human papillomavirus (hpv) is a causal factor in the development of hnsccs : as many as 5 to 10% of tumors are induced by hpv in the world, and it is responsible of 25,9% of hn tumors. hpv 16 is the most involved (87%). however, hpv epidemiology is different in west indies with the implication of various genotypes. detection of hpv infection can be achieved through several methods such as polymerase chain reaction (pcr) or rnascope, which is a new reliable precise technique which reflects the transcriptional activity of the virus. the differences between the genotype of hpv involved within both populations need to be consider to better identify therapeutic targets.studying the microenvironment may allow a better understanding of anti-tumoral immunity and may help patient selection in order to achieved better responses to immunotherapy.

Eligibility criteria:
inclusion criteria: * primitive head and neck squamous cells carcinoma diagnosed on surgical resection or biopsic sample, between 2008 and 2015 in metropolitan and antillean populations. for metropolitan they were included when expressing p16 as assessed by immunochemistry and positive hpv dna by in situ hybridation or positive hpv pcr. for antillean population they were included when expressing p16 as assessed by immunochemistry with regards of genotype as assessed by in situ hybridation or by pcr (to be completed). exclusion criteria: * secondary tumors, * tumor recurrence in a patient for whom we have already tumor tissue, nasopharyngeal tumors, p16 expression by immunochemistry with negative pcr testing for hpv.

Keywords: head cancers neck squamous cells carcinoma hpv immunotherapy
a study to assess the safety of experimental medication bms986165 in participants with normal kidney function and participants with mild to end-stage kidney disease.

Conditions: Renal Impairment; Healthy Volunteer

Summary: the purpose of this study is to investigate bms-986165 in participants with different levels of kidney function.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * participants must be judged to be in good health in the opinion of the investigator or participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration) * stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent egfr assessment; egfr must not vary more than 30% from screening to day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months * body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening exclusion criteria: * clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ecg, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant * have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit * history or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening other protocol defined inclusion/exclusion criteria could apply
pilot study of glycemic control in diabetic hemodialyzed patients

Conditions: Diabetes Mellitus

Summary: the purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (cgm) on glycemic control in hemodialyzed patients with diabetes

we conducted a pilot prospective multicenter study in five french centers (strasbourg university hospital, strasbourg sainte anne hospital, colmar, mulhouse, valenciennes) designed to evaluate the feasibility and effects of a 3 month treatment regimen with rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir, respectively) along with cgm on glucose level control in diabetic hemodialyzed patients. all patients who were admitted to the nephrology departments and matched the inclusion criteria between january 1st, 2010, and june 30th, 2012, were consecutively included in the study. cgm was used to analyze blood glucose excursions at baseline and 1 and 3 months of treatment. it was started during the first dialysis session and then continued for the next two days at home under ambulatory conditions. the cgm was continued during the next dialysis session. therefore, in total, cgm (navigator®; abbott, rungis, france) was performed for 54 hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of treatment. the probe for the system was subcutaneously inserted at the beginning of the first dialysis session to analyze interstitial glucose, and it was removed at the end of the second dialysis session. due to the time required for cgm calibration, plasma glucose levels were only partially recorded during the first dialysis session.

Eligibility criteria:
inclusion criteria: * age between 18 and 83 years * diagnosis of type 1 or type 2 diabetes * treatment with insulin injections or oral hypoglycemic agents * hba1c ≥ 7% (i.e., 53 mmol/mol) * on hemodialysis for more than three months exclusion criteria: * unstable anemia or blood transfusions within the two months prior to the beginning of the study * a life expectancy of less than 1 year * chronic inflammatory disease * evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery * noncompliant patients

Keywords: diabetes mellitus hemodialysis continuous glucose monitoring insulin analogues
evaluation of the accuracy and precision of the inratio® prothrombin time (pt) monitoring system with new inratio test strip designed for low sample volume and heparin insensitivity

Conditions: Pulmonary Embolism; Atrial Fibrillation; Deep Vein Thrombosis

Summary: this is a multi-center study designed to evaluate the accuracy and precision of the inratio® prothrombin time (pt) monitoring system, utilizing the inratio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of pt and international normalized ratio (inr) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (oat). these results will be compared to those pt/inr results obtained on plasma from the same subjects as analyzed at a central laboratory with the sysmex ca-560 system.


Eligibility criteria:
inclusion criteria: * adults (18 years of age or older); * willing and able to provide written informed consent and comply with study procedures; * subjects on oral anticoagulation therapy. this inclusion criterion is waived for the 20 normal healthy volunteers who must not be on warfarin or any other anticoagulant drug. exclusion criteria: * hematocrit less than 25 or greater than 55%; * lupus or antiphospholipid syndrome (aps) * vulnerable populations deemed inappropriate for study by the site's principal investigator. * already participated in this study.

Keywords: patients with conditions (pe, afib, dvt) requiring ongoing inr measurements.
trial using impella lp 2.5 system in patients with acute myocardial infarction induced hemodynamic instability

Conditions: Acute Myocardial Infarction

Summary: this is a randomized trial investigating the use of the impella recover lp 2.5 compared to intra-aortic balloon pump (iabp) in patients with acute myocardial infarction.


Eligibility criteria:
inclusion criteria: * informed consent * subject presenting with stemi undergoing primary pci * patient presents with at least 1 of the following: * unstable blood pressure * tachycardia and tissue hypoperfusion * the need for intravenous pressor or inotropic support * patient presents with stemi: * ck-mb\>2x normal exclusion criteria: * unwitnessed cardiac arrest * abnormalities of the aorta * recent stroke or tia * mural thrombus in the left ventricle

Keywords: arterial occlusive disease heart diseases myocardial ischemia vascular disease arteriosclerosis ischemia
sulodexide efficacy in chronic idiopathic subjective tinnitus

Conditions: Tinnitus, Subjective

Summary: the objective of this prospective randomized and double blind controlled study is to evaluate the efficacy and safety of sulodexide (25 mg) in the treatment of chronic idiopathic subjective tinnitus.

patients with chronic idiopathic subjective tinnitus, since at least 1 year, re recruited from our ear, nose and throat (ent) clinic. after verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1- sulodexide 25 mg for 40 days 2- placebo for 40 days. clinical evaluation of the patient is performed; tinnitus is assessed according to tinnitus handicap inventory score, mini tinnitus questionnaire score. adverse effects are also noted. patients are followed at 40 days post-treatment and outcome measures are assessed.

Eligibility criteria:
inclusion criteria: * tinnitus for minimum of 1 year * absence of psychiatric or neurological diseases * absence of any disease that explains tinnitus * noise-induced hearing loss * cochlear and retro-cochlear damage exclusion criteria: * conductive hearing loss * mixed hearing loss * meniere's disease * systemic vascular disease * diabetic disease * vestibular schwannoma * cerebello-pontine angle tumors * pulsatile tinnitus * pregnancy
functional outcome following fracture of the distal radius

Conditions: Distal Radius Fractures

Summary: patients attending the university hospital coventry uk with a broken wrist requiring an operation, will be invited to enter the study. at the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. the questions are to determine if they normally have pain in the wrist and how well they can perform their daily activities. the patient will then have an operation, and the fracture in the wrist will be held in the correct position with either a metal plate and screws or wires. at 6 weeks following the operation the patient will be reassessed and an xray will be taken. at 3 months, 6 months and 12 months after the operation patients will perform tests to assess the strength of their grip, pinch and movement of their wrist. in addition they will complete the the same questionnaires from their first visit. at the 12 month visit patients will have another xray.


Eligibility criteria:
inclusion criteria: * sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3cm of the radio-carpal joint * the treating consultant surgeon believes that they would benefit from operative fixation of the fracture * aged over 18years (either sex) and able to give informed consent exclusion criteria: * the fracture extends more than 3 cm from the radio-carpal joint * the fracture open with a gustillo grading greater than 1 * there are contra-indications to general anaesthetic * there is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires

Keywords: colles' fracture radius fracture grip strength pinch strength range of movement prwe dash eq-5d kirschner wire volar locking plate
percutaneous rupture of zygapophyseal joint cysts

Conditions: Zygapophyseal Synovial Joint Cyst

Summary: lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. these cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture

lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. these cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture. 30 patient with lower extremity radiculopathy caused by lumbar zygapophyseal joint cysts will be included in the study.

Eligibility criteria:
inclusion criteria: * patients with lumbar zygapophyseal joint cyst and compression of a spinal nerve root with lower extremity radiculopathy proven by mri. exclusion criteria: * infection, uncontrollable bleeding disorder

Keywords: zygapophyseal joint cyst fluoroscopy guided percutaneous lumbar
expressive writing in improving the wellbeing or comforting capacity of caregivers of patients with cancer

Conditions: Caregiver

Summary: this randomized clinical trial studies expressive writing in improving the wellbeing or comforting capacity of caregivers of patients with cancer. expressive writing is a type of intervention that asks people to write about important topics (in this case participants' experience with their spouses'/partners' cancer) and their emotions/feelings surrounding them. expressive writing, including benefit finding and traumatic disclosure, may be a type of at-home-therapy that caregivers can utilize in an attempt to increase their own wellbeing, offer better comfort to cancer patients, and by association, help cancer patients cope with and manage the cancer experience.

primary objectives: i. to test whether one, or both, types of expressive writing impact spouses of cancer survivors' reported emotional wellbeing and reported ability to provide comfort as compared to a control group. outline: patients are randomized to 1 of 2 arms or assigned to a control arm. arm i (expressive disclosure): participants complete an anonymous 20 minute writing exercise at home on their computer once per week for 2 weeks (days 2, 9, and 16 for a total of 3 sessions). participants write about their emotions pertaining to managing and providing care for the cancer patient. arm ii (benefit finding): participants complete an anonymous 20 minute writing exercise at home on their computer once per week for 2 weeks (days 2, 9, and 16 for a total of 3 sessions). participants write about any benefits that have arisen because of the cancer diagnosis. arm iii (control): participants complete an anonymous 20 minute writing exercise at home on their computer once per week for 2 weeks (days 2, 9, and 16 for a total of 3 sessions). participants write about an emotionally neutral topic. after completion of study, participants are followed up at day 17.

Eligibility criteria:
inclusion criteria: * participants must be a spouse or domestic partner of a cancer survivor and will be recruited via the hematopoietic stem cell transplant database at fred hutchinson cancer research center (fhcrc) * participants must have been in their spousal relationship for at least the past 1 year exclusion criteria: * if participants are unable to access a computer they will be excluded
treatment of prisoners with attention deficit hyperactive disorder in trondheim prison

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the treatment of adhd in jail will help the prisoners in their rehabilitation process

prisoners with adhd will be offered treatment with stratera, and we wanted to study their use of the prisons rehabilitation offers as school, programs and work training before and after treatment with stratera.

Eligibility criteria:
inclusion criteria: all prisoners that fullfill the diagnostic criterias for adhd - exclusion criteria: all other prisoners -

Keywords: attention deficit hyperactivity disorder, treatment, strattera, rehabilitation
phase i study of hbt-708 for patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study will be to evaluate the safety, tolerability, and inital efficacy of hbt-708 in subjects with advanced solid tumors.

this study is a study of hbt-708 monotherapy in advanced solid tumors. this study includes dose-escalation and dose-expansion cohort, with the accelerated titration combined 3+3 dose escalation method. the administration frequencies of hbt-708 is q3w i.v. all cohorts will assess the efficacy and safety of the preset several dose levels of hbt-708 in advanced solid tumors.

Eligibility criteria:
inclusion criteria: 1. male or female subjects, age 18 years or older. 2. histologically and/or cytologically documented advanced or measurable solid tumors. 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. life expectancey \> = 3 months. 5. willingness to provide written informed consent for the study. exclusion criteria: 1. known uncontrolled or symptomatic central nervous system metastatic disease. 2. subjects must have recovered (≤ grade 1 or pretherapy baseline) from aes due to previously administered therapies. (national cancer institute common terminology criteria \[nci ctcae\] v.5.0). 3. inadequate organ or bone marrow function. 4. pregnant or breast-feeding woman. 5. known allergies, hypersensitivity, or intolerance to hbt-708 the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: solid tumors
fibrin glue or tranexamic acid for total knee arthroplasty

Conditions: Knee Arthropathy

Summary: objectives: a) principal: to assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee. secondaries: to assess the treatment safety. to perform a cost- analyses. methods: randomized, unicentric, and parallel clinical trial with four comparative groups: tissucol® (fibrin glue), fibrin glue manufactured by the cryoseal® system (banc de sang i teixits de catalunya), tranexamic acid and habitual haemostasia. nº of participant centres: 1. random allocation will be centralised. main outcome: blood losses (ml) in the post-operatory period collected by the habitual drain system. secondary outcomes: proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed. size sample calculation: the number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals. statistical analysis: the investigators will perform a comparison of outcomes through the "t" test, the mann-whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. the software used will be statistical package for the social sciences (spss) version 17.


Eligibility criteria:
inclusion criteria: * total knee arthroplasty * the patient consent to participate exclusion criteria: * intolerance drugs to the study or to bovine protein (aprotinin) * antecedent of thromboembolic disease * patient with cardiac alterations of the rhythm * patients with valvular cardiac prosthesis * patients with pro-thrombotic alterations of coagulation * treatment with anticonceptive drugs

Keywords: primary knee arthroplasty fibrin glue tranexamic acid topic